Effect of Transcutaneous Auricular Neurostimulation on Mental Wellness and Resiliency for First Responders: A Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- GAD-7
研究概览
简要总结
This study is designed as an open label, single arm, decentralized clinical study in which first responders will receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) via the mastoid and the auriculotemporal nerve (ATN) anterior to the tragus. Participants will be enrolled in the study over the course of eight weeks (56 days).
Participants will respond to daily and weekly questionnaires regarding mood, stress, sleep, energy/fatigue, and burnout. Each week, participants will complete consolidated online questionnaires (intended to last no longer than 15 minutes) comprised of the Perceived Stress Short-Form (PSS-4), Well-Being Index (WHO-5), Mini-Z Burnout (5-item), PROMS Sleep Disturbance (PROMIS-SD), GAD-7 (every 2 weeks), and Perceived Stress (PSS-10; monthly). The PSS-10 will replace the PSS-4 on Days 0, 28, and 56.
No tAN treatment will be delivered during the Baseline Period (days between Study Introduction and Day 0). Participants will complete the weekly set of questionnaires ("Weekly Questionnaires") on Day 0. Participants will be recommended to complete the daily set of questionnaires ("Daily Questionnaires ") on the other days of the Baseline Period.
On Days 1 - 28, participants will self-administer one session of one to two hours of tAN therapy each day. Participants will be recommended to complete the daily tAN session post-shift prior to sleep. Weekly Questionnaires will be completed by participants on Study Days 0, 7, 14, 21, 28, 35, 42, 49, and 56. Participants will be recommended to complete Daily Questionnaires on all other study days, up to Day 28. Daily Questionnaires will not be required to be completed by participants. Daily tAN sessions and Daily Questionnaires will cease after Day 28. Participants will complete a Study Satisfaction Questionnaire with the Weekly Questionnaires on Day 56.
Following Day 56, participants will schedule a Study Exit Interview with the Research Coordinator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is currently employed in a first responder position
- •Age ≥ 18 years
- •Reliable access to an internet-enabled device to complete required questionnaires
- •GAD-7 score ≥ 5
排除标准
- •Participant has a history of epileptic seizures
- •Participant has a history of neurologic diseases or traumatic brain injury
- •Participant has presence of devices (e.g., pacemakers, cochlear prostheses or implants, neurostimulators)
- •Participant has abnormal left ear anatomy or ear infection present
- •Participant has auditory impairment of the left ear (ruptured eardrum, deafness, tinnitus, etc.)
- •Participant is currently enrolled in another interventional trial
- •Women of childbearing potential, not using adequate contraception as per the investigator's judgement
- •Females who are pregnant or lactating
- •Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
研究组 & 干预措施
Active tAN
First responders will self-administer once-daily active tAN sessions for 1-2 hours for 28 days. Participants will complete daily and weekly assessments to evaluate levels of stress, mood, energy/fatigue, sleep quality , and burnout. Daily assessments and tAN sessions will cease after Day 28. Participants will continue to complete weekly assessments until Day 56.
干预措施: Sparrow Link (Device)
结局指标
主要结局
GAD-7
时间窗: Screening, Day 0, Day 14, Day 28, Day 42, Day 56
The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research. The questionnaire consists of 7 questions in which participants are asked to rate each item on a 0 (not at all) to 3 (nearly every day). GAD-7 total score for the seven items ranges from 0 to 21 where 0-4 represents minimal anxiety, 5-9 represents mild anxiety, 10-14 represents moderate anxiety and 15-21 represent severe anxiety.
次要结局
- WHO-5 Well-Being Index(Weekly throughout enrollment beginning Day 0 through Day 56))
- Perceived Stress Scale (PSS-4, PSS-10)(Weekly throughout enrollment beginning Day 0 through Day 56))
- PROMIS Sleep Disturbance(Weekly throughout enrollment beginning Day 0 through Day 56))
- Mini-Z Burnout Survey(Weekly throughout enrollment beginning Day 0 through Day 56))